Hinge for orthopedic device

ABSTRACT

A hinge has a hinge body forming an articulating section extending between a first end and a second end of the hinge. The articulating section is adapted to bend from a neutral axis when the first and second ends are parallel to an angular range in which the first end is arranged among a plurality of angles within the angular range relative to the second end. The hinge body may define a receptacle along the articulating section, and an insert may be provided for insertion into the receptacle. The insert can modify the stiffness of the hinge in the angular range and is arranged parallel to the neutral axis.

BACKGROUND

Hinges are arranged in orthopedic devices and guide or assistarticulation of a joint, such as a knee joint. Some hinges are robust,including multiple parts and structural elements, and facilitate andguide movement of a joint. Such robust hinges may not be necessary inapplications of lighter-weight orthopedic devices in that theirfunctional and structural features may be excessive. Such robust hingesmay add to weight, cost, bulk, resistance to joint movement, andcomplexity of an orthopedic device. When such aspects are unwarranted,they are to the disadvantage of a user.

As an alternative to the robust hinges, some lighter-weight orthopedicdevices include a lightweight hinge, such as a stay, upright, orflexible bar permitting articulation of the orthopedic device. Thesehinges permit articulation in a manner that reinforces the orthopedicdevice upon bending but are less intended for facilitating movement ofjoint. The lightweight hinges may be embedded or securely enclosedwithin a panel such as a tubular sleeve in the orthopedic device, and donot engage or couple to other structural features in the orthopedicdevice, aside from the tubular sleeve.

While these hinges offer joint guidance and support, and retain at leastin part the shape of the orthopedic device when defined as a flexibletubular sleeve, they are not adaptable to different characteristicsincluding rigidity, strength, and range or motion control, particularlyaccording to different activity levels. These lightweight hinges may belimited in their use as defining elongate members that have no otherfunction or features aside from opening as a hinge or a stay. There is aproblem of lightweight hinges not providing sufficient control orguidance of motion in one or more directions. Additionally, there is aproblem of existing lightweight hinges not adapting to the dynamic shapeof a user's lib, especially between flexion and extension, while stillproviding needed strength and effectively cooperating with otherelements of an orthopedic device, such as a compressive sleeve.

SUMMARY

Embodiments of a hinge for an orthopedic device provided herein overcomethe problems of existing hinges by offering a hinge made from a lightand flexible material for optimum shape and fit. In an example, thehinge may be adaptable to an orthopedic device, such as in a compressiveknee sleeve requiring a tight-fitting form and streamlined outline. Thehinge may further streamline the structure in a compressive orthopedicdevice by providing means for mounting straps, for example in openings,slots and retainers, and by providing a multi-purpose structure that canguide, facilitate and limit bending within an angular range, andoffering a structure for repeated use of a strap for securing andutilizing the orthopedic device on a user. The means for mounting strapscan be arranged to direct straps in predetermined directions.

Contrary to many conventional hinges which comprise discrete components,the hinge of the disclosure preferably includes a monolithic hinge bodyformed from a single material and continuously extends withoutinterruption from a first end to a second end of the hinge. The singlematerial structure may be formed from a polymeric material that may beless hard than metal materials as found in conventional hinges, andnecessitates no moving parts and fasteners. The single materialstructure may be compliant and adapted to flexibly bend not just withinan angular range, but also transversely relative to a neutrallongitudinal axis of a leg or joint in extension to contourlongitudinally end to end to a variable radius of a user's limb, such asin an upper leg (including a thigh) and lower leg (including a calf).The gentle adaptation of the hinge to the user's leg enables a betterand closer fit of the orthopedic device on the user.

The articulating portion of the hinge may be reinforced, and may bestiffer at an articulating section to provide angular control of ajoint. Because the hinge has a single hinge body, it can be adapted andformed according to different limb lengths, and strengthened andstiffened with variable resiliency or elasticity from longitudinal endto end. The articulating section preferably protrudes minimally from theorthopedic device, and occupies a minimal space over the user's leg.Advantageously, the articulating section minimizes substantial rigidstructure along the medial and lateral sides of the orthopedic device,which does not or minimally interferes with the opposing knee of theuser or the natural motion of the leg. This allows the orthopedic deviceto fit snugly to the leg, while conforming to the shape of the leg andoffering assistance to the natural motion of the knee between extensionand flexion.

According to an embodiment, a hinge includes a hinge body forming anarticulating section extending between first and second ends of thehinge. The hinge body is adapted to bend from a neutral axis when thefirst and second ends are parallel to an angular range in which thefirst end is arranged among a plurality of angles within the angularrange relative to the second end. The articulating section has anadjustable floating center variable radius within the angular rangebecause the variable radius changes according to flexion of the hinge.

The hinge body may define a receptacle along the articulating section.An insert is arranged for insertion into the receptacle, and can modifythe stiffness of the hinge in the angular range. The insert ispreferably arranged parallel to the neutral axis. The insert may have anelongate shape toward a length of the insert, with a greater thicknessrelative to a width of the insert. In this manner, a curvature of theinsert occurs along the width, and into the thickness of the insert,thereby facilitating bending while maintaining sufficient strengthaccording to repeated use.

Properties of the insert may be selected according to the desiredproperties at the articulating section. The insert may be more resilientthan the hinge body with elastic properties greater than thearticulating section, to provide spring-back from the angular range toreturn the hinge to the neutral axis. The insert may be selectedaccording to a stiffness to modify stiffness of the articulatingsection. The insert may be formed from a different material than thehinge body, or may be from the same material of the hinge body, but isselected according to its properties and intended benefits imparted tothe articulating section. The insert may be removable from the hingebody to switch between different inserts, or the properties of the hingeprovided by the absence of the insert may be desirable. The hinge bodymay define a slot through which the insert may be applied to and removedfrom the receptacle.

As the hinge body may be continuously formed, it is preferably a singlepiece of injection molded plastic, longitudinally elongated. The hingebody defines an asymmetric structure because it has localized regionsproviding different functions for both articulation and strength alongthe longitudinal length. Aside from rings or strap slots, the hinge bodymay form a rib protruding from a base thickness of the hinge body atleast along the articulating section in the longitudinal direction ofthe hinge body. The rib may form a maximum thickness in a middle of thearticulating section and resist articulation within the angular range orreinforce the articulating section while facilitating bending. The ribmay taper in height toward first and second ends to the base thickness.

In supplement to or replacing the rib, the hinge body may have a firstwidth transverse to the neutral axis and outside the articulatingsection, and a second width in the articulating section that is morenarrow than the first width. The hinge body may define include first andsecond struts arranged on opposed ends of the articulating section. Thefirst and second struts may have a first width, with the articulatingsection between the first and second struts and having a second widthmore narrow than the first width. There may be a transition from thefirst width to the second width whereat the width gradually tapers fromthe first width to the second width. The second width may be defined ina region of the articulating section elongate along the longitudinallength of the hinge body, and the rib may coincide with the second widthto maintain strength of the articulating section while permittingflexibility by the narrower second width.

As an orthopedic device, the hinge may be combined with a tubular sleevethat can compressively secure about a limb. The tubular sleeve may beformed from a textile panel. The hinge may be secured on the tubularsleeve or in a pocket or other suitable retaining features for securingthe hinge onto or within the tubular sleeve. In an orthopedic deviceforming a knee support, the hinge is adapted to bend toward an anteriorside of the knee support, leaving a posterior recess on the posteriorside of the knee support. The textile panel may be reinforced with asupplementary panel retaining the hinge between the supplementary paneland the textile panel, and being contoured similarly to a profile of thehinge without substantially protruding outwardly from the orthopedicdevice. Straps may secure to the hinge, and extend about or over theorthopedic device, with the hinge being rigid compared to the textilepanel. The hinge may be provided with other types of orthopedic devicesas considered useful, and may be adapted accordingly.

By providing the hinge for an orthopedic device according to thedisclosure, the hinge provides needed strength and stability to theaffected joint of the user, while dynamically conforming to the limb'schanging dimensions through flexion and extension, and while cooperatingwith other components of the orthopedic device, e.g. the compressivetubular sleeve. These functions—dynamic accommodation of the limb,strength and support, and cooperation—are harmonized by the hinge of thedisclosure, with no function being sacrificed for another as in existinghinges.

Additional features and advantages of the disclosure will be set forthin the description that follows, and in part will be obvious from thedescription, or may be learned by the practice of the disclosure. Thefeatures and advantages of the disclosure may be realized and obtainedwith the instruments and combinations particularly pointed out in theappended claims. These and other features of the present disclosure willbecome more apparent from the following description and appended claimsor may be learned by the practice of the disclosure as set forth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an orthopedic device including anembodiment of a hinge.

FIG. 2 is a plan view of the hinge of FIG. 1.

FIG. 3 is a side elevational view of the hinge of FIG. 2.

FIG. 4 is a perspective cross-sectional view of the hinge in FIG. 2taken along line IV-IV.

FIG. 5 is a perspective cross-sectional view of the hinge in FIG. 2taken along line V-V.

FIG. 6A is a side elevational view of an insert in the hinge of FIG. 2.

FIG. 6B is a front elevational view of the insert of FIG. 6A.

FIG. 7 is a detail view of FIG. 1 without the strap in FIG. 1.

FIG. 8A is a rear plan view of another embodiment of a hinge.

FIG. 8B is a front plan view of the hinge of FIG. 8A.

FIG. 8C is an elevational view of the hinge of FIG. 8A.

FIG. 9A is a front plan view of another embodiment of a hinge.

FIG. 9B is an elevational view of the hinge of FIG. 9A.

FIG. 10 is a perspective view of another embodiment of a hinge.

FIG. 11 is a schematic view of another embodiment of a hinge as part ofan orthopedic device.

FIG. 12A is a plan view of another embodiment of a hinge in extension.

FIG. 12B is a plan view of the hinge in FIG. 12A in flexion.

FIG. 12C is a plan view of another embodiment of a hinge in extension.

In the figures, similar elements are provided with similar referencenumbers. The drawing figures are not drawn to scale, or proportion, butinstead are drawn to provide a better understanding of the components,and are not intended to be limiting in scope, but provide exemplaryillustrations.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Overview

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are in thedrawings and are described below. It should be understood, however,there is no intention to limit the disclosure to the specificembodiments disclosed, but on the contrary, the intention covers allmodifications, alternative constructions, combinations, and equivalentsfalling within the spirit and scope of the disclosure.

B. Environment and Context of Embodiments

Embodiments of the hinge described herein may be provided in anorthopedic device of the type discussed in U.S. patent application Ser.No. 15/672,593, filed on Aug. 9, 2017, published as U.S. patentapplication publication no. 2018/0042754, on Feb. 15, 2018, andincorporated herein by reference.

For further ease of understanding the embodiments of an orthopedicdevice in the exemplary form of a textile support for treatingcomplications of the knee and variants as disclosed, a description of afew terms is necessary.

As used herein, the term “flexion” should denote a condition in which alimb, for example a leg, is bent at an articulating joint, such as aknee. The term “extension” is intended to denote a condition in which alimb, for example a leg, is unbent or straightened at an articulatingjoint, such as a knee. The term “stiffness” has its ordinary meaning asthe degree of resistance of an elastic body to deflection or deformationby an applied force, and more particularly to bending between end pointsin the context of a hinge.

The terms “rigid,” “flexible,” “compliant,” and “resilient” maydistinguish characteristics of portions of certain features of thehinge. The term “rigid” should denote that an element of the device isgenerally devoid of flexibility. Within the context of features that are“rigid,” it is intended to indicate that they do not lose their overallshape when force is applied, and may break if bent with sufficientforce. The term “flexible” should denote that features are capable ofrepeated bending such that the features may be bent into retained shapesor the features do not retain a general shape, but continuously deformwhen force is applied.

The term “compliant” may qualify such flexible features as generallyconforming to the shape of another object when placed in contacttherewith, via any suitable natural or applied forces, such asgravitational forces, or forces applied by external mechanisms. The term“resilient” may qualify such flexible features as generally returning toan initial general shape without permanent deformation. As for the term“semi-rigid,” this term may be used to connote properties of supportmembers or shells that provide support and are freestanding; however,such support members or shells may have some degree of flexibility orresiliency. The term “elastic” may connote stretchability, and the term“semi-elastic” connotes various degrees of elasticity as compared to theterm “inelastic” which may mean devoid or substantially devoid of anyelasticity.

C. Various Embodiments of the Hinge and Association with an OrthopedicDevice

FIG. 1 depicts an orthopedic device 100 having a tubular support 101forming a generally tubular shape. The tubular support 101 is preferablyfunctionally knit and may comprise different zones of varying knittedpatterns or formations, and is not limited to being formed from aknitted material; rather it can be formed from a foam or other suitablematerial used in orthopedic devices. The tubular support 101 may besupplemented with a supplementary panel or panels 103 that correspond toa hinge 102, the hinge 102 extending longitudinally between first andsecond ends 109, 111, and the tubular support 101 may form a pocket orother retaining structure for the hinge 102.

In this embodiment, the orthopedic device 100 includes straps 104, 106tethered to first and second, in this instance upper or lower,respectively, rings 108, 110 formed by the hinge 102. More particularly,the straps 104, 106 extend about a forward portion 112 of the first andsecond rings 108, 110, toward an anterior side A of the orthopedicdevice 100, and can be pulled against the forward portion 112 as thestraps 104, 106 are tensioned. The straps 104, 106 may return to one ofthe first and second rings 108, 110 on or from a posterior side P of theorthopedic device 100, such that the first and second rings 108, 110 canretain a plurality of strap ends extending in opposing or at leastdifferent directions. As shown, the straps 104, 106 may secure directlyto the orthopedic device 100, such as by being secured to the tubularsupport 101 or supplementary panel 103.

The hinge 102 is preferably retained by the orthopedic device 100 by ahinge cover 114 formed by the supplementary panel 103. The hinge 102 maybe removably secured within or by the hinge cover 114, or may bepermanently secured by the hinge cover 114. By “permanently” it is meantthat one must separate at least a portion of the hinge cover 114 in anirreversible manner to withdraw the hinge 102 from the orthopedic device100, and “removably” means one can repeatedly remove the hinge 114 fromthe orthopedic device 100 without irreversible alteration of the hingecover 114 or the tubular support 101.

FIG. 1 exemplifies how the hinge 102 has an anterior compartment 156that protrudes anteriorly toward the knee, and a notched posteriorcompartment 158 that offers a recess opening posteriorly of the knee. Inthis manner, there is no pinching of the hinge 102, particularlyposteriorly, and the structure on the medial and lateral aspects of theknee along the sagittal plane is minimized. Both the anterior andposterior compartments 156, 158, as covered by the hinge cover 114, mayhave differing or similar arcuate shapes, according to the degree offlexion. Such an arrangement reduces pressure over the knee, whileoffering structural integrity and conformity of the individual anatomyof a user at the articulating section 107 of the knee according to themeans in the articulating section 107 discussed below according to thedifferent embodiments. The hinge cover 114 may be configured accordingto the shape of the hinge 102 as it moves from extension to flexion, asdepicted by the varying shapes of the anterior and posteriorcompartments 156, 158.

As depicted in FIG. 1, the hinge 102 comprises a hinge body 105 and isarranged to flex within the hinge cover 114 in a manner that minimizesspace taken by the hinge 102 at the knee. As referred to herein as thearticulating section 107, it is evident that because the hinge 102 has anarrow articulating section 107, there is less interference by the hinge102 where the knee bends. In some conventional braces, a correspondingarticulating section may protrude outwardly and risk interference withthe user's other knee or any brace the user is wearing. The articulatingsection of such devices may also fail to accommodate the dynamicdimensions of the knee. In the hinge 102 of the instant disclosure, thearticulating section 107 offers the flexion control of the knee withoutthe attendant drawbacks of the prior art.

While depicted as generally being on one of the medial or lateral sidesof the tubular support 101, the hinge 102 may be provided on both themedial and lateral sides of the tubular support 101.

As shown in more detail in FIGS. 2-5, the hinge 102 has rear portions116, 118 of the rings 108, 110 to reinforce forward portions 112, 124,and are configured and dimensioned to distribute pressure exerted by thestraps 104, 106 over the leg of the user while the first and secondrings 108, 110 maintain their shape despite the forces exerted by thestraps 104, 106. The hinge 102 may be symmetric in shape so as to bereadily useable on both lateral and medial sides of the orthopedicdevice 100, or may be asymmetric by accounting for anatomicaldifferences in upper and lower legs. The first and second rings 108, 110each define an opening 120, 122 to reduce weight and coverage of thefirst and second rings 108, 110 over the user's leg, and also facilitatereception of a strap 104, 106 therethrough. The first and second rings108, 110 may or may not be symmetric in shape, individually orcollectively.

The hinge 102 defines first and second struts 132, 134 that transitionfrom transitional portions 140 from the rings 108, 110 and have a widthwl along their length. The struts 132, 134 and the rings 108, 110 arepreferably semi-rigid or rigid to offer support to the user's leg, andso as not to yield due to tensioning of the straps 104, 106.

An insert 126 may be provided with the hinge 102 to selectively modifythe rigidity of the hinge 102. The insert 126 may be elongate as inhaving length greater than its width, and preferably extends in alongitudinal direction along the length of the hinge. Specifically, thehinge 102 may be formed of a rigid or semi-rigid plastic, such as froman EVA polymer, and its rigidity can be enhanced at least at anarticulation area, such as a middle portion 128 of the hinge 102 whereit is intended to bend. The middle portion 128 of the hinge 102 issubstantially narrowed to a reduced width w2 via tapering first andsecond transitional portions 136, 138 in comparison to the first andsecond struts 132, 134 leading from the middle portion 128 to the rings108, 110. The narrow middle portion 128 facilitates bending of the hinge102, and forms a receptacle 142 (see FIGS. 4 and 5) that is adapted toreceive the insert 126. The insert 126 may be provided in a set ofinserts 126 adapted to be received by the receptacle 142, and eachinsert 126 of the set of inserts may possess different stiffnesses. Theinsert 126 may have a substantially elongate configuration because theinsert 126 extends primarily longitudinally.

While the insert 126 is described as being inserted into the receptacle142 and selectively removed therefrom, the insert 126 may be permanentlyplaced in the receptacle 142 after the hinge body 105 is formed so thatthe insert 126 is permanently placed in the receptacle 142. The insert126 may be inserted into the hinge body 105 as it is cooling so there isat least partial bonding of the material of the insert 126 with thematerial of the hinge body 105. An adhesive may permanently mount theinsert 126 to the hinge body 105. By understanding “permanently,” thismeans that the insert 126 cannot be removed from the hinge body 105without physically causing damage or deterioration to either the insert126 or the hinge body 105.

The middle portion 128 may include a raised rib portion 130 at itsgreatest height or thickness t3 along the middle portion 128, and tapersto a reduced thickness t2 along tapering portions 131 along the firstand second struts 132, 134 to its minimal thickness tl at the first andsecond rings 108, 110. The middle portion 128 may also define windows144, 146 through at least the rib portion 130 to show the insert 126.The insert 126 may be color coded depending on its stiffness orresiliency, and the windows 144, 146 expose the color of thecorresponding insert 126 as an indicator to a user of the presenceand/or stiffness of the insert 126. The rib portion 130 or ridges formedthereby facilitate bending of the hinge 102 in a sagittal plane, butresist bending in a coronal plane.

The preferred embodiment shows the hinge 102 as being monolithicallyformed, meaning that it is formed as a single body, withoutinterruptions, and is unitary in shape and function. The hinge 102 maybe formed by injection molding from a single mold and material depositedin such single mold, without additionally attaching other features tothe hinge 102 after the injection molding of the hinge 102. Themonolithic hinge body 105 spans the length of the hinge 102, and whileit may be supplemented with the insert 126, the single body of the hingebody 105 can individually serve as a hinge without the insert 126 or anyother additional component or adaptation.

The perspective cross-sectional view of FIG. 4 shows the arrangement ofthe receptacle 142 within the hinge body 105 in the embodiment of FIGS.1-5. The receptacle 142 is configured to receive the insert 126 in adirection parallel to the neutral axis of the hinge 102, therebyallowing the insert 126 to aid in adjusting the degree of flexion onlyin desired directions.

Likewise, the perspective cross-sectional view of FIG. 5 shows thespatial configuration of the receptacle 142 in the embodiment of FIGS.1-5. Receptacle 142 is configured to receive a flat, elongate insert 126within the raised portion of the hinge body 105, facilitating variableflexion of the hinge 102 and the insert 126 along a width of the insert126.

FIGS. 6A, 6B show an exemplary insert 126. While not limited to thedepicted shape, the insert 126 may be configured and dimensioned tosnugly fit within the receptacle 142 formed by the hinge 102. The insert126 may be formed from a plastic or metal, but regardless of the choiceof material should have sufficient resiliency to return to its shapefrom flexion to extension of the hinge 102. As with the rib portion 130or ridges of the hinge 102, the insert 126 is configured anddimensioned, and placed in the receptacle 142 correspondingly defined,to facilitate bending in the sagittal plane but resist bending in thecoronal plane. The insert 126 has a width w3 substantially less than itsthickness t4, which are both substantially less than its length 11.These dimensions facilitate the insert 126 to resist bending in thecoronal plane but to be receptive to bending in the sagittal plane.

FIG. 7 shows a detail of the hinge 102 secured to the tubular support101. An opening or slot 148 is defined between or within the ring 108,particularly at the forward portion 112, with the slot 148 having innerand outer sides 150A, 150B. The strap (shown in FIG. 1) is adapted toinsert through the slot 148, and fold over itself so it is biasedagainst the forward portion 112. The tubular support 101 may bereinforced proximate the ring 108 which extends from strut 114, andabout the hinge 102, with reinforcement elements 152 attached to thetubular body 101 to account for areas in combination with the hinge 102to resist or reinforce movement or sliding. FIG. 7 also shows that astrap 106 may secure about the rearward portion 116 of the ring 108,thereby forming a multi-directional strap connector.

FIGS. 8A-8C depict another embodiment of a hinge 400 for an orthopedicdevice, with the hinge 400 comprising first and second struts 402, 404.Struts 402, 404 are arranged to extend longitudinally and uniformlyalong the user's leg above and below the knee and have a single widthw4. Transition portions 424, 428 attach struts 402, 404 to a middleportion 430 having a narrower width w5 than the width w4 of the struts402, 404.

Instead of rings 108, 110 of the embodiment of FIGS. 1-5, struts 402,404 define slots 416, 418, 420, 422 along a length of the struts 402,404. Slots 416, 418, 420, 422 facilitate the attachment of multiplestraps and reduce the size, weight, and material cost of the hinge 400.

As in the embodiment depicted in FIG. 1, the hinge 400 comprises a rib406 at the middle portion 430, the rib 406 defining a raised portionhaving a thickness t5 sufficient to receive an insert 426 therein. Onone side of the hinge 400, a receptacle 414 is provided to facilitateinsertion and retention of the insert 426. On the opposite side of thehinge 400, windows 410, 412 allow a user to see the insert 426 and anyindicia provided thereby. In other embodiments, the insert 426 may beplaced within the receptacle 414 on the same side as the windows 410,412.

In contrast to the embodiment of FIGS. 1-5, the hinge 400 of FIGS. 8A-8Cmay define a center portion of the struts 402, 404 having a uniformthickness t5 along the length of the hinge 400, rather than tapering inthickness from a maximum thickness at the rib and having a minimumthickness at the first and second ends.

FIGS. 9A and 9B depict yet another embodiment of a hinge 500. As inprevious embodiments, first and second struts 502, 504 longitudinallyextend from a middle portion 530 and attach to the middle portion 530 attransition portions 508, 510. Struts 502, 504 have a width w6 greaterthan a width w7 of the middle portion 530.

The first and second struts 502, 504 of the embodiment of FIGS. 9A and9B define wing portions 520, 522 that extend obliquely from the struts502, 504 over the user's leg proximate the first and second ends of thehinge 500. The wing portions 520, 522 advantageously provide addedtraction and stability on the underlying tubular support, especially astorque is applied via straps. The wing portions 520, 522 may be securelyplaced into corresponding receiving structure of an orthopedic device(such as in pockets) to prevent the hinge 500 from popping from theorthopedic device when straps are pulled or upon force. Preferably, thewing portions 520, 522 are directed in opposite directions to the forceincurred by the straps. The wing portions 520, 522 may be adapted in avariety of shapes aside from those depicted, including curved, hook orpronged shapes for creating and maintaining traction with the orthopedicdevice, as in a textile panel.

As in the embodiment of FIGS. 8A-8C, struts 502, 504 define strap slots512, 514, 516, 518 extending longitudinally between first and secondends of the hinge 500. Slots 512, 514, 516, 518 are configured tosupport one or more straps around the underlying tubular support and theuser's leg and reduce the size, weight, and material cost of the hinge500. A skilled artisan will understand that more or fewer slots may beprovided, and in different locations.

Struts 502, 504 have a thickness t6 that is less than a thickness t7 ofa rib 506 defined at the middle portion 530. The greater thickness t7 ofthe rib 506 accommodates an insert 526, allowing a user or clinician tovary the stiffness of the hinge 500 as necessary. The rib 506 may be insupplement to or in place of an insert. Variations of the hinge 500 maybe adapted with a receptacle for placement of an insert, or any of theembodiments herein may have an articulating section reinforced with abolstered thickness, as depicted in FIG. 9B. Areas outside of the rib506 may be modified accordingly to facilitate bending or localizingbending of the hinge 500 at the articulating section in correspondencewith the rib 506.

FIG. 10 depicts another embodiment of a hinge 200, having first andsecond bolsters 202, 204, extending from first and second struts 206,208. The bolsters 202, 204 may be provided as stays to the orthopedicdevice, or may be modified similarly to the rings 108, 110 in theembodiment of FIG. 1. A rib 210 may extend from the struts 206, 208, andreinforce a middle portion 211 of the hinge 200. Straps 232, 234 areconfigured to extend from bolsters 202, 204 analogous to the extensionof straps 104, 106 from rings 108, 110 in the embodiment of FIG. 1, andby so doing secure the tubular support 220 in a comfortable andconvenient manner.

The middle portion 211 defines a first set of hinge elements 212, witheach first hinge element 214 adapted to facilitate and reinforce bendingof the middle portion 211. The middle portion 211 defines a second setof hinge elements 216, with each second hinge element 218 adapted tofacilitate and reinforce bending of the middle portion 211. The secondset of hinge elements 216 may be arranged to limit the range of motionof the hinge 200, as depicted in FIG. 12B. The second set of hingeelements 216 are geometrically configured to interfere with one anotheraccording to a predetermined degree of bending, which is advantageous tolimit the bending of a knee of a user when wearing the orthopedicdevice.

FIG. 11 depicts an arrangement whereby the bolsters 202, 204 areseparate from the struts 206, 208, or are formed in greater size. Thesebolsters 202, 204 may be thinner than the struts 206, 208 and cover asignificant portion of the tubular support 220.

FIGS. 12A and 12B illustrate another hinge embodiment 300. In thisembodiment, the hinge 300 has first and second struts 302, 304, with amiddle portion 305 therebetween. The hinge 300 includes first and secondsets of hinge elements 306, 310, each with corresponding first andsecond hinge elements 308, 312 having predetermined geometricalconfigurations according to the desired range of motion of the hinge300. As shown in FIG. 12B, the second set of hinge elements 310 aregeometrically configured to limit the bending of the hinge 300 at apredetermined angle of flexion. The first set of hinge elements 306 arearranged to freely permit bending of the hinge 300 to a greater degreethan the second set of hinge elements 310.

As shown in FIG. 12C, an insert 314 may be located along the middleportion 305 of the hinge 300, as with the insert 126 of FIG. 1. Theinsert 314 may be located or is preferably located along the midspan ofthe hinge 300, and is elongate between the hinge elements 308, 312. Areceptacle, retaining elements or slots 316 may be formed by the hinge300 to hold the insert 314.

It is to be understood that not necessarily all objects or advantagesmay be achieved under any embodiment of the disclosure. Those skilled inthe art will recognize that the hinge for an orthopedic device may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other objects or advantages as taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousdisclosed features. Besides the variations described, other knownequivalents for each feature can be mixed and matched by one of ordinaryskill in this art to construct hinge for an orthopedic device underprinciples of the present disclosure. It will be understood by theskilled artisan that the features described may be adapted to othertypes of hinges and/or orthopedic devices. Hence this disclosure and theembodiments and variations thereof are not limited to hinges for softknee braces, but can be utilized in any hinge for any orthopedic device.

Although this disclosure describes certain exemplary embodiments andexamples of a hinge for an orthopedic device, it nevertheless will beunderstood by those skilled in the art that the present disclosureextends beyond the specifically disclosed hinge embodiments to otheralternative embodiments and/or uses of the disclosure and obviousmodifications and equivalents thereof. It is intended that the presentdisclosure should not be limited by the particular disclosed embodimentsdescribed above, and may be extended to other hinges for otherorthopedic devices and supports, and other applications that may employthe features described herein.

1. A hinge, comprising: a hinge body forming an articulating sectionextending between a first end and a second end of the hinge and adaptedto bend from a neutral axis when the first end and the second end areparallel to an angular range in which the first end is arranged among aplurality of angles within the angular range relative to the second end,the hinge body defining a receptacle along the articulating section; aninsert arranged for insertion into the receptacle, the insert modifyingthe stiffness of the hinge in the angular range and arranged parallel tothe neutral axis.
 2. The hinge of claim 1, wherein the hinge body iscontinuously formed from a single material from the first end to thesecond end of the hinge.
 3. The hinge of claim 1, wherein the hinge bodycontinuously extends without interruption from the first end to thesecond end of the hinge in a longitudinal direction along the neutralaxis.
 4. The hinge of claim 4, wherein the hinge body forms a first ringat the first end of the hinge.
 5. The hinge of claim 4, wherein thefirst ring defines a first ring portion on an anterior side of thehinge, and a second ring portion on a posterior side of the hinge, thefirst ring portion having a different shape than the second ringportion.
 6. The hinge of claim 5, wherein the first ring portion definesa generally elongate bar, and the second ring portion forms a curvature.7. The hinge of claim 1, wherein the hinge body forms a rib protrudingfrom a base thickness of the hinge body at least along the articulatingsection in a longitudinal direction along the neutral axis.
 8. The hingeof claim 7, wherein the rib forms a maximum thickness in a middle of thearticulating section and resists articulation within the angular range.9. The hinge of claim 7, wherein the rib tapers in height toward thefirst end and the second end to the base thickness.
 10. The hinge ofclaim 1, wherein the hinge body tapers from a first width transverse tothe neutral axis to a second width in the articulating section.
 11. Thehinge of claim 1, wherein the hinge body includes a first strut and asecond strut each arranged on opposed ends of the articulating section,the first strut and the second strut having a first width transverse tothe neutral axis, and the articulating section having a second widthmore narrow than the first width.
 12. The hinge of claim 11, wherein thehinge body tapers from the first width to the second width.
 13. Thehinge of claim 11, wherein the second width is located generallyequidistant between the first end and the second end of the hinge body,and extends a length longitudinally along the neutral axis short of anentirety of the articulating section.
 14. The hinge of claim 1, whereinthe insert has an elongate shape in the direction of a length thereof,the insert having a width transverse to the length shorter than athickness parallel to the length.
 15. The hinge of claim 1, wherein theinsert has a greater stiffness than the articulating section of thehinge body.
 16. The hinge of claim 1, wherein a first section of thehinge body extending from a first side of the articulating section tothe first end of the hinge body is symmetric with a second section ofthe hinge body extending from a second side of the articulating sectionto the second end of the hinge body.
 17. The hinge of claim 1, wherein afirst section of the hinge body extending from a first side of thearticulating section to the first end of the hinge body is reverselyarranged relative to a second section of the hinge body extending from asecond side of the articulating section to the second end of the hingebody.
 18. The hinge of claim 1, wherein the articulating section formsat least one slot for removably placing the insert within thereceptacle.
 19. A hinge, comprising: a hinge body forming anarticulating section extending between a first end and a second end ofthe hinge and adapted to bend from a neutral axis when the first end andthe second end are parallel to an angular range in which the first endis arranged among a plurality of angles within the angular rangerelative to the second end; the hinge body being formed from a singlematerial and continuously extending without interruption from the firstend to the second end of the hinge in a longitudinal direction along theneutral axis; wherein the hinge body forms a rib protruding from a basethickness of the hinge body at least along the articulating section inthe longitudinal direction along the neutral axis, the hinge bodygenerally having the base thickness outside of the articulating section,and the rib forming a maximum thickness in a middle of the articulatingsection and resisting articulation within the angular range; wherein thehinge body includes a first strut and a second strut each arranged onopposed ends of the articulating section, the first strut and the secondstrut having a first width transverse to the neutral axis, and thearticulating section having a second width more narrow than the firstwidth, the hinge body tapering from the first width to the second width.20. A hinge, comprising: a hinge body forming an articulating sectionextending between a first end and a second end of the hinge and adaptedto bend from a neutral axis when the first end and the second end areparallel to an angular range in which the first end is arranged among aplurality of angles within the angular range relative to the second end,the hinge body defining a receptacle along the articulating section; aninsert arranged for insertion into the receptacle, the insert modifyingthe stiffness of the hinge in the angular range and arranged parallel tothe neutral axis; the hinge body being formed from a single material andcontinuously extending without interruption from the first end to thesecond end of the hinge in a longitudinal direction along the neutralaxis; wherein the hinge body forms a first ring at the first end of thehinge, and a second ring at the second end of the hinge; wherein a firstsection of the hinge body extending from a first side of thearticulating section to the first end of the hinge body is reverselyarranged relative to a second section of the hinge body extending from asecond side of the articulating section to the second end of the hingebody.